Study to Examine Safety, Tolerability and Effect on Body Weight of Subcutaneous AC2307 in Obese or Overweight Subjects

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00785408

Collaborator

(none)

273

Enrollment

Locations

Arms

Duration (Months)

15.2

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to examine the safety, tolerability, and effect on body weight of subcutaneous AC2307 in obese or overweight subjects.

Condition or Disease	Intervention/Treatment	Phase
Obesity Overweight	Drug: AC2307 Drug: placebo Drug: AC2307 Drug: placebo Drug: AC2307 Drug: placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

273 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Examine the Safety, Tolerability, and Effect on Body Weight of Subcutaneous AC2307 in Obese or Overweight Subjects

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: AC2307 subcutaneous, twice daily, low dose
Experimental: 2	Drug: AC2307 subcutaneous, twice daily, middle dose
Experimental: 3	Drug: AC2307 subcutaneous, twice daily, high dose
Placebo Comparator: 4	Drug: placebo subcutaneous, twice daily, low dose
Placebo Comparator: 5	Drug: placebo subcutaneous, twice daily, middle dose
Placebo Comparator: 6	Drug: placebo subcutaneous, twice daily, high dose

Outcome Measures

Primary Outcome Measures

To examine the effect on body weight of AC2307 injected subcutaneously (SC) twice daily (BID) in obese or overweight subjects [24 weeks]
To assess the safety and tolerability of AC2307 injected SC BID in obese or overweight subjects [24 weeks]

Secondary Outcome Measures

To examine the effect of AC2307 injected SC BID in obese or overweight subjects on the following parameters: waist circumference; gastric emptying rate; fasting circulating metabolic parameters; patient reported outcomes [24 weeks]
To examine the pharmacokinetics of AC2307 injected SC BID in obese or overweight subjects [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Is obese with a body mass index (BMI) ≥30 kg/m^{2 to ≤45 kg/m}2, or is overweight with a BMI ≥27 kg/m^{2 to <30 kg/m}2 and has at least one weight-related comorbidity (dyslipidemia, impaired fasting glucose, hypertension, obstructive sleep apnea syndrome, polycystic ovary syndrome, and/or osteoarthritis)

Exclusion Criteria:

Has had a major change in daily physical activity (e.g., initiation of an exercise program) or has been enrolled in a weight loss program within 2 months prior to study start
Has received AC2307 or pramlintide in a clinical study or has received prior treatment with pramlintide (SYMLIN®) or calcitonin
Has received any investigational drug within 1 month or within a period corresponding to five times the half-life of the investigational drug, whichever is greater, before study start
Has donated blood within 2 months before study start or is planning to donate blood during the study

Contacts and Locations

Locations

	Site	City	State	Country
1	Research Site	Birmingham	Alabama	United States
2	Research Site	Chandler	Arizona	United States
3	Research Site	Santa Rosa	California	United States
4	Research Site	Walnut Creek	California	United States
5	Research Site	Denver	Colorado	United States
6	Research Site	Jacksonville	Florida	United States
7	Research Site	Miami	Florida	United States
8	Research Site	Chicago	Illinois	United States
9	Research Site	Overland Park	Kansas	United States
10	Research Site	Baton Rouge	Louisiana	United States
11	Research Site	Butte	Montana	United States
12	Research Site	Cincinnati	Ohio	United States
13	Research Site	Eugene	Oregon	United States
14	Research Site	Medford	Oregon	United States
15	Research Site	Greer	South Carolina	United States
16	Research Site	Mt. Pleasant	South Carolina	United States
17	Research Site	Austin	Texas	United States
18	Research Site	Olympia	Washington	United States